Pfizer, BioNTech announce results from vaccine trial in kids

Sept. 20, 2021

Pfizer and BioNTech have announced promising results from a highly anticipated trial studying the effectiveness and safety of their COVID-19 vaccine for children ages 5 to 11, as pediatric cases in the U.S. have risen by 240% since July.

The data summarized was from a phase 2/3 study — which is enrolling children 6 months to 11 years of age — and consisted of 2,268 participants who were 5-11 years of age and received a 10 µg dose level in a two-dose regimen. The trial used a smaller vaccine dosage rather than the 30 microgram dose used for people 12 and older.

The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16-25 years of age immunized with 30 µg doses. The vaccine was shown to be safe and well tolerated, according to Pfizer and BioNTech,

The partners plan to share the data with the U.S. FDA, the EMA and other regulators as soon as possible. According to BioNTech CEO Dr. Ugur Sahin,  this should happen before the start of the winter season.

Read the press release